Primary source: Swissmedic
The guidance specifies that MAHs must update their safety database systems to comply with the E2B(R3) specifications and verify their connections with the B2B gateway by August 1, 2026.
This operational change is vital for ensuring continued compliance with Swiss pharmacovigilance reporting standards and avoiding disruptions in the reporting process.
MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.
Regulatory Intelligence Lead
Review before 2026-08-01.
The updated guidance (version 2.0) includes revised technical specifications for the B2B gateway transmission of ICSRs, clarifying the requirements following the full phase-out of the E2B(R2) process. It provides updated information on connection tests and the processing of individual case reports.
MAHs reporting to Swissmedic must ensure their safety database systems are configured to the updated E2B(R3) specifications. PV operations teams should verify the connection with the B2B gateway and update internal reporting SOPs to reflect the finalization of the E2B(R3) transition.
MAHs must adapt to new electronic reporting format and conditions
Switch from E2B(R2) to E2B(R3) format
MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.
The updated guidance provides Marketing Authorisation Holders (MAHs) with revised technical specifications for the electronic exchange of Individual Case Safety Reports (ICSRs) using the E2B(R3) standard, effective August 1, 2026. MAHs must ensure their systems are compliant with E2B(R3) and confirm connections with the B2B gateway.
What changed: The guidance specifies that MAHs must update their safety database systems to comply with the E2B(R3) specifications and verify their connections with the B2B gateway by August 1, 2026.
Why it matters: This operational change is vital for ensuring continued compliance with Swiss pharmacovigilance reporting standards and avoiding disruptions in the reporting process.
Practical implication: MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.
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